Pulmonary HypertensionEarly Phase 1NCT07662655
Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study
A Early Phase 1 study testing Percutaneous Pulmonary Artery Denervation (PADN) in people with Pulmonary Hypertension and Pulmonary Hypertension Associated With HFpEF, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF
- What is being tested?
- Percutaneous Pulmonary Artery Denervation (PADN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2026to 31 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤80 years;
- Diagnosed with pulmonary hypertension (defined as mPAP >20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;
- No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);
- Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;
- Willing to comply with the treatment and follow-up schedule required by the protocol
Who cannot join
- Cardiac index (CI) < 1.5 L/min/m²;
- Severe renal insufficiency (creatinine clearance rate (CrCL) < 30 mL/min);
- Left ventricular ejection fraction (EF) <30% on echocardiography;
- Severe hematological disease or severe bleeding tendency (platelet count <10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
- Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;
- Acute systemic infectious disease;
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- Poor general condition due to various systemic diseases;
- Pulmonary veno-occlusive disease;
- Cachexia;
- Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
- Anticipated to undergo other surgical or interventional procedures within 6 months;
- Life expectancy <12 months;
- Allergy to the drugs or metal materials used in the study;
- Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
- Participation in another drug or medical device clinical trial within 3 months prior to screening;
- Any condition deemed unsuitable for participation in this clinical trial by the investigator. |
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
Xiamen, Fujian, 361000
Xiang Chen, 18033997788, seanchenx@126.com
About this study
this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making
- Being tested
- Percutaneous Pulmonary Artery Denervation (PADN), Control group (receiving standard medical therapy alone)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Pulmonary Artery Denervation (PADN)Device
PADN Procedure Steps:
- Non-Selective Pulmonary Artery Angiography
- PADN Ablation Target Selection
- Hemodynamic Assessment
- Establishment of the PADN® RF Catheter Delivery Rail
- PADN® RF Catheter Delivery
- Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds.
- Completion of the PADN
Control group (receiving standard medical therapy alone)Drug
Control group (receiving standard medical therapy alone)
| Study group | Role | What they receive |
|---|---|---|
| PADN group (receiving PADN plus standard medical therapy) | Experimental | PADN group (receiving PADN plus standard medical therapy) Receives: Device: Percutaneous Pulmonary Artery Denervation (PADN) |
| Control group (receiving standard medical therapy alone) | Placebo comparator | Control group (receiving standard medical therapy alone) Receives: Drug: Control group (receiving standard medical therapy alone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening event
defined as the occurrence of any of the following:
- Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators);
- Heart failure-related rehospitalization;
- Decrease in 6MWD from baseline by >10% or >30 meters;
- Need for heart/lung transplantation;
- All-cause death
Measured: From enrollment up to 12 months
Secondary outcomes (15)
Changes from baseline in pulmonary vascular resistance (right heart catheterization)
Changes from baseline in pulmonary vascular resistance (PVR); Unit of measure: Wood units
Measured: From enrollment up to 12 months
Changes from baseline in echocardiographic linear dimension parameters
Changes from baseline in right atrial diameter (RAD), left atrial diameter (LAD), left ventricular internal diameter at end-diastole (LVIDd), left ventricular posterior wall thickness at end-systole (LVPWd), and tricuspid annular plane systolic excursion (TAPSE); Unit of measure: millimeters (mm)
Measured: From enrollment up to 12 months
Changes from baseline in echocardiographic percentage functional indices
- Parameters: Ejection fraction (EF), right ventricular fractional area change (RV-FAC)
- Unit of measure: percentage (%)
Measured: From enrollment up to 12 months
Changes from baseline in cardiac output (right heart catheterization)
- Parameter: Cardiac output (CO)
- Unit of measure: liters per minute (L/min)
Measured: From enrollment up to 12 months
Changes from baseline in WHO functional class
Measured: From enrollment up to 12 months
Changes from baseline in NT-proBNP/BNP
Measured: From enrollment up to 12 months
Changes from baseline in 6-minute walk distance (6MWD)
Measured: From enrollment up to 12 months
Changes from baseline in Short Form-36 (SF-36) Health Survey scale score
The SF-36 scale ranges from 0 to 100, where higher scores indicate a better outcome (Minimum = 0, Maximum = 100).
Measured: From enrollment up to 12 months
All-cause rehospitalization rate
Measured: From enrollment up to 12 months
Incidence of worsening heart failure symptoms requiring intravenous therapy
Measured: From enrollment up to 12 months
Heart failure-related rehospitalization rate
Measured: From enrollment up to 12 months
Rate of need for heart/lung transplantation
Measured: From enrollment up to 12 months
Changes from baseline in intracardiac pressure parameters (right heart catheterization)
- Parameters: mean right atrial pressure (mRAP), right ventricular systolic pressure (RVSP), pulmonary artery systolic pressure (PASP), pulmonary artery diastolic pressure (PADP), mean pulmonary artery pressure (mPAP), pulmonary artery wedge pressure (PAWP)
- Unit of measure: millimeters of mercury (mmHg)
Measured: From enrollment up to 12 months
Changes from baseline in cardiac index (right heart catheterization)
- Parameter: Cardiac index (CI)
- Unit of measure: liters per minute per square meter (L/min/m²)
Measured: From enrollment up to 12 months
Changes from baseline in pulmonary arterial compliance (right heart catheterization)
- Parameter: Pulmonary arterial compliance (PAC)
- Unit of measure: milliliters per millimeter of mercury (mL/mmHg)
Measured: From enrollment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start6 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Chen, Xiamen Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662655
- Sponsor's protocol ID
- 2026KY001
- Status last verified
- Jun 2026
- First submitted
- 2 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07662655
- Acronym / sponsor ID
- 2026KY001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 6 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PADN group (receiving PADN plus standard medical therapy) | Experimental | Device: Percutaneous Pulmonary Artery Denervation (PADN)PADN group (receiving PADN plus standard medical therapy) |
| Control group (receiving standard medical therapy alone) | Placebo comparator | Drug: Control group (receiving standard medical therapy alone)Control group (receiving standard medical therapy alone) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and ≤80 years;
- Diagnosed with pulmonary hypertension (defined as mPAP >20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;
- No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);
- Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;
- Willing to comply with the treatment and follow-up schedule required by the protocol
Key exclusion criteria (16 listed)
- Cardiac index (CI) < 1.5 L/min/m²;
- Severe renal insufficiency (creatinine clearance rate (CrCL) < 30 mL/min);
- Left ventricular ejection fraction (EF) <30% on echocardiography;
- Severe hematological disease or severe bleeding tendency (platelet count <10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
- Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Pulmonary Artery Denervation (PADN)PADN Procedure Steps: 1. Non-Selective Pulmonary Artery Angiography 2. PADN Ablation Target Selection 3. Hemodynamic Assessment 4. Establishment of the PADN® RF Catheter Delivery Rail 5. PADN® RF Catheter Delivery 6. Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds. 7. Completion of the PADN | Device | PADN group (receiving PADN plus standard medical therapy) |
| Control group (receiving standard medical therapy alone)Control group (receiving standard medical therapy alone) | Drug | Control group (receiving standard medical therapy alone) |
Primary outcome
Clinical worsening event
Time frame: From enrollment up to 12 months
defined as the occurrence of any of the following: 1. Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators); 2. Heart failure-related rehospitalization; 3. Decrease in 6MWD from baseline by >10% or >30 meters; 4. Need for heart/lung transplantation; 5. All-cause death
15 secondary outcomes
Changes from baseline in pulmonary vascular resistance (right heart catheterization)
Time frame: From enrollment up to 12 months
Changes from baseline in echocardiographic linear dimension parameters
Time frame: From enrollment up to 12 months
Changes from baseline in echocardiographic percentage functional indices
Time frame: From enrollment up to 12 months
Changes from baseline in cardiac output (right heart catheterization)
Time frame: From enrollment up to 12 months
Changes from baseline in WHO functional class
Time frame: From enrollment up to 12 months
Changes from baseline in NT-proBNP/BNP
Time frame: From enrollment up to 12 months
Changes from baseline in 6-minute walk distance (6MWD)
Time frame: From enrollment up to 12 months
Changes from baseline in Short Form-36 (SF-36) Health Survey scale score
Time frame: From enrollment up to 12 months
All-cause rehospitalization rate
Time frame: From enrollment up to 12 months
Incidence of worsening heart failure symptoms requiring intravenous therapy
Time frame: From enrollment up to 12 months
Heart failure-related rehospitalization rate
Time frame: From enrollment up to 12 months
Rate of need for heart/lung transplantation
Time frame: From enrollment up to 12 months
Changes from baseline in intracardiac pressure parameters (right heart catheterization)
Time frame: From enrollment up to 12 months
Changes from baseline in cardiac index (right heart catheterization)
Time frame: From enrollment up to 12 months
Changes from baseline in pulmonary arterial compliance (right heart catheterization)
Time frame: From enrollment up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Percutaneous Pulmonary Artery Denervation (PADN) in people with Pulmonary Hypertension and Pulmonary Hypertension Associated With HFpEF, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang CHEN, Dr (+8618033997788, seanchenx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening event (time frame: From enrollment up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.